Q&A

OssDsign is an innovator, designer and manufacturer of implants and material technology for bone regeneration. We are surgeons, scientists and engineers - committed to improving outcomes in cranioplasty and facial reconstructive surgery.

Clinical experiences with OssDsign's products have shown low observed rates of post-operative complications. Evidence of long-term bone regeneration has been published in peer reviewed journals.

OssDsign has in-house manufacturing facility in Uppsala, Sweden.

The OssDsign calcium-phosphate material is a blend of Monetite, ß-tri calcium phosphate and ß-calcium pyrophosphate.

Please see Kihlström et al. 2018, Engstrand et al. 2015, Engstrand et al. 2014.

The implant is MR Conditional. Please see the full Instructions for Use for further information.

In mechanical testing, OssDsign Cranial PSI has shown to withstand up to two times the load as the comparative titanium mesh [Kihlström et al. 2018]. The ceramic tiles of Cranial PSI are connected by a titanium skeleton. The titanium component between the tiles is slightly thinner than the remainder of the main skeleton to provide local deformation zones, independent of the ceramic tile. If the implant withstands an external load, the deformation zones will absorb a large part of the load. These zones provide local flexibility, further shielding the ceramic tiles from damage.

OssDsign Facial is also reinforced with similar non-exposed, high-strength titanium.

Store between 4-34°C (40-93°F)

OssDsign Cranial PSI is delivered sterile and is confirmed to remain sterile for one year from date of manufacture. The sterilization method used by OssDsign is steam sterilization (20 minutes, 121°C). 

No, the implants should not be re-sterilized.

The implant is attached to surrounding bone using tapered (counter-sunk) titanium screws inserted into the fixation arms. The fixation arms can be slightly bent for optimized fixation. No drilling or modification is required. More information on the surgical procedure can be found in the Instructions for Use.

Yes, however there is no need to soak OssDsign Cranial implants before implantation.

A surgical incision directly above the implant increases the risk of wound dehiscence and subsequent infection and should be avoided if possible. If this approach can not be avoided, the use of vertical mattress suturing technique is recommended. https://www.youtube.com/watch?v=824FhFUJ6wc

To order an OssDsign product you need an account in OssDsign’s Customer Communication Platform (CCP). CCP is based on a technology platform that ensures secure data handling and storage. Registered customers can manage their order requests and communicate with our Customer Service and Design Engineers in a secure and easy way.

Contact order@ossdsign.com or your local OssDsign representative and we will help you get started.

The implant is shipped from OssDsign’s facilities in Sweden 4 weeks after the digital design proposal and quote is approved by the customer.

CT scanning guidelines are available for download at ossdsign.com/order. Please contact us for more information.

No, CT according to scanning guidelines is currently the only option.

A price quote and a proposed implant design is sent to the ordering surgeon no later than two working days after the order and CT documentation have been received at OssDsign.

The implants are delivered in a sterile packaging together with an instructive photo of the specific case.